endobj For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. /S /URI More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. I used it a few times and Im good now. I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. /TT0 69 0 R The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. Faced with negative publicity, they often end up making things right. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /StructParents 6 September 30, 2021 09:03 ET /Filter /FlateDecode For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. << Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. We were asked to improve the ease of donning . I have one new for sale. Hi Wally, Hope someone is able to meet your request. It has made my life miserable. I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? >> (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. Except for my wrist, all my measurements showed reduction. Positive value shows an increase in Function/Range of Motion. 11 0 obj /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. /Tabs /S Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? >> << https://doi.org/10.1007/s00520-020-05540-8, 3. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. Reading or watching TV are the activities Im able to do while Im being treated. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. I just finished 6 weeks of radiation. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ 18 0 obj I knew Dr. Stanley Rockson of Stanford University was performing a drug trial with a medication called Uberimex for the treatment of lymphedema so I was keenly interested in learning what he said about this new pump. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Negative value shows a decrease in swelling. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. >> endobj The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /TT3 74 0 R In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? I was rather startled at how wrapped up I was. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. >> I would contact your local news station that has a consumer investigation/help line. endstream https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. Sort by. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /Type /Page S Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv Ml6(|a\!A.;Q#[. << /Group << /StructParents 0 /Resources << /TT0 22 0 R /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. /Type /Page Top reviews. /Type /Page My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. 1. Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. Thank you for sharing and being an advocate for lymphedema! I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. /Length 680 As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. 35 0 R] The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. >> Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. This is not anadvertisement for Flexitouch.). /Type /Page The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. << /Filter /FlateDecode /Type /Action /Tabs /S Words like new kind of pump, different than the old types, favorable studies, and Dr. Actually they dont know much about lymphedema. >> 17 0 obj /ProcSet [/PDF /Text /ImageC] Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. Hi Kathi, The FaceTime call might work! 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 1 0 obj When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. k Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endobj 4? I need help but theres a no return policy. The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Tens of thousands of. My therapist said they cannot be reused by another. /TT2 71 0 R It delivers a noninvasive therapy that patients can administer themselves at home. /Parent 2 0 R >> More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. . I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. /CS /DeviceRGB /Subtype /Link 2008-2023 HMP Global, Inc. All rights reserved. Talk with your doctor and family members or friends about deciding to join a study. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. << Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Contents 73 0 R For general information, Learn About Clinical Studies. So we appealed 3 times. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. My husband has a brand new system that Im trying to sell. Oral Oncology. I was told purchased high priced left garments which I dont think I needed.